China NMPA Product Recall - Electronic turbidimeter

bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its electronic turbidimeter following the discovery of critical labeling inaccuracies. The issue originated from a complaint received by bioMérieux USA, Inc., which subsequently triggered an internal investigation at the manufacturing plant. This inquiry confirmed that the Chinese label on the inner packaging of the affected product contained an incorrect registration certificate number and an inaccurate registrant's address.

The recall was reported on February 2, 2021, and publicly announced on February 22, 2021, through the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration Website. Although specific inspection dates were not disclosed, the company's internal investigation led to the identification and rectification of this discrepancy.

Under the regulatory framework of the NMPA, bioMérieux Diagnostics (Shanghai) Co., Ltd. is proactively addressing this non-conformity. The required action involves the voluntary retrieval of all affected electronic turbidimeter units, identifiable by Registration Certificate No.: 国械注进20182222238. This action underscores the company's commitment to maintaining accurate product information and adhering to regulatory standards, ensuring consumer confidence and compliance within the medical device market. Further details on specific models and batch numbers are available in the official "Medical Device Recall Event Report Form."